Methods of treating eosinophilic esophagitis by administering an antibody which inhibits interleukin-4 receptor (IL-4R)

Abstract

The present invention provides methods for treating, preventing or reducing the severity of eosinophilic esophagitis. The methods of the present invention comprise administering to a subject in need thereof a therapeutic composition comprising an interleukin-4 receptor (IL-4Rα) inhibitor such as an anti-IL-4Rα antibody.

What is claimed is: 
     
       1. A method of treating or ameliorating at least one symptom of eosinophilic esophagitis (EoE) in a subject, the method comprising administering to the subject one or more doses of an interleukin-4 receptor (IL-4R) inhibitor, wherein the IL-4R inhibitor is an antibody or antigen-binding fragment thereof that binds IL-4Rα and comprises a heavy chain complementarity determining region (HCDR)1 comprising the amino acid sequence of SEQ ID NO:3, an HCDR2 comprising the amino acid sequence of SEQ ID NO:4, an HCDR3 comprising the amino acid sequence of SEQ ID NO:5, a light chain complementarity determining region (LCDR)1 comprising the amino acid sequence of SEQ ID NO:6, an LCDR2 comprising the amino acid sequence of SEQ ID NO:7, and an LCDR3 comprising the amino acid sequence of SEQ ID NO:8, and wherein the IL-4R inhibitor is administered to the subject subcutaneously or intravenously. 
     
     
       2. The method of  claim 1 , wherein, prior to the onset of treatment the subject exhibits an esophageal eosinophilic infiltration of ≥15 eosinophils per high-power field as measured by esophageal biopsy. 
     
     
       3. The method of  claim 1 , wherein the subject is inadequately responsive to treatment with a swallowed topical corticosteroid. 
     
     
       4. The method of  claim 1 , wherein the subject is inadequately responsive to diet modification. 
     
     
       5. The method of  claim 1 , wherein the subject has concomitant food allergy, atopic dermatitis, asthma, or allergic rhinitis. 
     
     
       6. The method of  claim 1 , wherein the subject is an adult. 
     
     
       7. The method of  claim 1 , wherein the IL-4R inhibitor is administered subcutaneously. 
     
     
       8. The method of  claim 1 , wherein each dose of the IL-4R inhibitor is from 50 mg to 600 mg. 
     
     
       9. The method of  claim 8 , wherein each dose of the IL-4R inhibitor is 300 mg. 
     
     
       10. The method of  claim 1 , wherein the IL-4R inhibitor is administered once a week, once every two weeks, once every three weeks, or once a month. 
     
     
       11. The method of  claim 1 , wherein the IL-4R inhibitor is administered at a dose of 300 mg once a week or once every two weeks. 
     
     
       12. The method of  claim 1 , wherein the antibody or antigen-binding fragment thereof comprises a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO:1 and a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO:2. 
     
     
       13. The method of  claim 1 , wherein the antibody or antigen-binding fragment thereof comprises a heavy chain comprising the amino acid sequence of SEQ ID NO:13 and a light chain comprising the amino acid sequence of SEQ ID NO:14. 
     
     
       14. The method of  claim 1 , wherein the antibody or antigen-binding fragment thereof is dupilumab or a bioequivalent thereof. 
     
     
       15. The method of  claim 1 , wherein the IL-4R inhibitor is contained in a syringe. 
     
     
       16. The method of  claim 1 , wherein the IL-4R inhibitor is contained in a pen delivery device.